The U.S. Army Medical Research and Materiel Command announced today theresults of a five-year trial of a candidate vaccine for treatment of HIVinfections.
While gp160 was hoped to slow the progression of the disease,unfortunately, results from the study show no clinical improvement that couldbe attributed to the vaccine used as adjunct therapy for HIV infection.
The purpose of the study was to determine: (1) whether the vaccine could slowthe progression of HIV disease in individuals already infected with the virus;(2) if these immunologically threatened and compromised individuals couldrespond to the active ingredients of the vaccine; and (3) the feasibility ofconducting such a large, complicated long term study.
Investigators concluded that the study yields the following significantinformation:
-- This was the first successfully concluded HIV vaccine therapy trial everperformed with a genetically engineered vaccine.
Data indicated that adjunctvaccine therapy with gp160 was not clinically effective.
-- Although the vaccine did not slow the progression of the disease, it didgenerate an elevated immune response in vaccinated subjects, and it had noadverse effects.
-- The study demonstrates that multi-year, interagency, multi-medical centertrials can be successfully conducted in early-stage, HIV-infected volunteersubjects.
Enrollment of volunteer subjects in the study began in November 1990.
Whenfollow-up with volunteers ended in December 1995, 608 study subjects had beenenrolled, and given regular injections of either the vaccine or a placebo everytwo months.
Of the 608 volunteers enrolled in the study, 483 completed thestudy, 104 dropped out of the study, and 21 volunteers died before the studywas completed.
The compliance and follow up of this study was 83 percent.
Medical researchers at the Walter Reed Army Institute of Research conductedthe study in collaboration with Army, Navy, and Air Force physicians, theNational Institute of Allergy and Infectious Diseases and civilian medicalcenters in the United States.
The vaccine was provided by Microgenesys Inc. ofMeriden, Conn.